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Improving Outcomes After Time Sensitive Prehospital Interventions: Rescu Epistry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110912
Recruitment Status : Withdrawn (No longer proceeding with application)
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

Brief Summary:
Rescu Epistry includes data points pertaining to prehospital and in-hospital clinical treatments and responses to therapy, survival to discharge and functional outcome data for all cases.

Condition or disease Intervention/treatment
Cardiac Arrest Sepsis Trauma Stroke Other: This is a registry and no interventions are taking place.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Outcomes After Time Sensitive Prehospital Interventions: Rescu Epistry
Study Start Date : January 2015
Estimated Primary Completion Date : December 2040
Estimated Study Completion Date : December 2040

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cardiac arrest
Ischaemic heart disease is the leading cause of death worldwide. However, this is a registry and no interventions are taking place
Other: This is a registry and no interventions are taking place.
Trauma
Worldwide, trauma is the number one cause of death and disability in people younger than 40 and confirmed for Canada as well for those under the age of 45. However, this is a registry and no interventions are taking place
Other: This is a registry and no interventions are taking place.
Sepsis
Sepsis is a clinical syndrome that results from dysregulation of the inflammatory response to severe infection. However, this is a registry and no interventions are taking place
Other: This is a registry and no interventions are taking place.
Stroke
Stroke is the second leading cause of death worldwide, and the leading cause of chronic disability. However, this is a registry and no interventions are taking place
Other: This is a registry and no interventions are taking place.



Primary Outcome Measures :
  1. Data Registry [ Time Frame: 1 year (annual) ]
    To collect comprehensive, standardized, multicentre prehospital data to guide future EMS and Fire as well as in-hospital care (e.g. Emergency Department (ED), Trauma Room, Critical Care Units (CrCU), ward care and rehabilitation) for cardiac arrest, trauma, stroke, and sepsis patients.


Secondary Outcome Measures :
  1. Effectiveness and Translation [ Time Frame: 1 year (annual) ]
    To evaluate the relationships between outcome and regionalized patient care systems, identify best practices, and compliance with guidelines and scientific statements or current evidence. (Effectiveness and Translation)

  2. Evaluation [ Time Frame: 1 year (annual) ]
    To use Rescu Epistry as the data collection interface to enable the evaluation of innovative strategies, including drugs, techniques and technology, and system changes to treat acutely ill patients with cardiac arrest, trauma, stroke, and sepsis in the prehospital setting through for example cohort studies, controlled clinical trials, and knowledge translation implementation trials. (Efficacy)

  3. International Collaboration in both Efficacy and Effectiveness [ Time Frame: 1 year (annual) ]
    To expand Rescu Epistry data collection to include other regions of care in Canada to provide provincial and national data sets and opportunities to collaborate internationally when increased sample sizes and cross border comparisons are required to advance the science quickly.

  4. Examine epidemiologic and outcomes [ Time Frame: 1 year (annual) ]
    To examine epidemiologic and outcomes aspects of acutely ill patients by linking Rescu Epistry to the existing health administrative data in Ontario contained at the Institute for Clinical Evaluative Sciences.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All persons within the catchment area of any EMS agency participating, including infants, children and adult patients requiring activation of the emergency 9-1-1 system that meet the defined criteria for cardiac arrest, traumatic injury, stroke or sepsis.
Criteria

Inclusion Criteria:

Cardiac Arrest Eligibility

  1. Individuals of all ages who experience cardiac arrest outside the hospital, with evaluation by organized EMS personnel and:

    • Attempts at external defibrillation (by lay responders or emergency personnel), or chest compressions by organized EMS personnel (treated cohort)
    • Were pulseless but did not receive attempts to defibrillate or CPR by EMS personnel (untreated cohort - obviously dead by legislative definition)

    Traumatic Injury Eligibility

  2. Individuals of all ages who experience a traumatic injury outside the hospital, with evaluation by organized EMS personnel and:

    • Systolic blood pressure ≤ 90 mmHg or
    • Glasgow Coma Scale score ≤12 or
    • Respiratory rate <10 or >29 breaths per minute or
    • Field intubation/advanced airway procedure

    Stroke Eligibility

  3. individuals of all ages who experience stroke outside the hospital, with evaluation by organized EMS personnel and new onset of signs and symptoms suggestive of an acute stroke

    • Unilateral arm/leg weakness or drift or
    • Slurred speech or inappropriate words or mute or
    • Unilateral facial droop

Sepsis Eligibility

  1. Potentially Septic: Individuals of all ages who present with

    • Presence of Fever: Temperature >38°C (tympanic membrane)
    • Paramedic suspects possible infection: i.e. suspected pneumonia, urinary tract infection, abdominal pain or distension, meningitis, cellulitis, septic arthritis, infected wound (minimal data set )
  2. Severe Sepsis: Individuals of all ages who also present with:

    • Presence of Fever: Temperature >38°C (tympanic membrane)
    • Paramedic suspects possible infection: e.g. suspected pneumonia, urinary tract infection, abdominal pain or distension, meningitis, cellulitis, septic arthritis, infected wound; Presence of any one of: (1) respiratory rate > 22/min or intubated for respiratory support; (2) acute confusion or reduced level of consciousness; (3) presence of hypotension: SBP<=100mmHg (comprehensive data set)

Exclusion Criteria: None,


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110912


Locations
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Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 1C3
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
St Michael's Hospital
Toronto, Ontario, Canada, M5V 1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Canada
Publications of Results:
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT04110912    
Other Study ID Numbers: Rescu Epistry
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by St. Michael's Hospital, Toronto:
Cardiac arrest, Trauma, Acute stroke, and Sepsis
Additional relevant MeSH terms:
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Heart Arrest
Cardiovascular Diseases
Heart Diseases